Lumbar Disc HerniationNCT07085247
The Role of Cutibacterium Acnes in the Development of Degenerative Lumbar Intervertebral Disc Disease
An observational study of Lumbar Disc Herniation and Lumbar Disc Degeneration, run by Masaryk University at 1 site in Czechia.
Trial summary
The goal of this study is to clarify the role of the bacterium Cutibacterium acnes in the development of degenerative disc disease in patients with lumbar disc herniation who underwent microdiscectomy as part of their regular medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Disc Degeneration, Cutibacterium Acnes
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We plan to enroll at least 400 patients with lumbar disc herniation indicated for microdiscectomy at the Department of Neurosurgery, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic. Patients indicated for lumbar microdiscectomy will be prospectively screened, and those who pass the inclusion and exclusion criteria will be asked to sign the Informed Consent form to be enrolled in the study.
Who may be able to join
- minimum age of 18 years
- MRI of the lumbosacral spine performed one month ± 2weeks before surgery showing a disc protrusion, herniation, or free nucleus pulposus sequestration
- matching physical examination findings including positive straight leg raise test, dermatomal sensory deficits, myotome motor deficits, and diminished deep tendon reflexes.
Who cannot join
- antibiotics or corticosteroid use the month before surgery
- ongoing bacterial or viral infection
- immunocompromised patient
- trauma
- undefined radiological mass
- inflammatory arthritis
- other rheumatologic diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
St. Anne´s University Hospital Brno
Brno, 60200
Peter Solár, MD, +420 549 491 111, peter.solar@fnusa.cz
Radim Jan, Prof. MD., +420543181111, radim.jancalek@fnusa.cz
About this study
Official title: The Role of Cutibacterium Acnes in the Development of Degenerative Lumbar Intervertebral Disc Disease and the Clinical Effect of Microdiscectomy
The goal of this study is to clarify the role of the bacterium Cutibacterium acnes in the development of degenerative disc disease in patients with lumbar disc herniation who underwent microdiscectomy as part of their regular medical care.
Read the detailed description
The project is divided into retrospective and prospective parts. The retrospective part will consist of data processing and analysis using our large cohort of patients enrolled during the previous studies. The prospective part will include a) patient enrollment, b) preoperative data collection, c) perioperative tissue collection, d) microbiological examination, e) postoperative follow-up visits, and f) data management and statistical analyses.
Retrospective data processing and analysis For the retrospective part of the project, the investigators plan to use the C. acnes database stored at the Department of Neurosurgery, St. Anne's University Hospital, Brno, Czech Republic. This database contains 1200 anonymized adult patients with symptomatic lumbar disc herniation scheduled for microdiscectomy between 2015 and 2024. These patients were enrolled during the research project entitled "Presence of the low-virulence bacterium Propionibacterium acnes in the intervertebral disc tissue as a cause of chronic back pain". Each patient signed informed consent forms before enrolling in this study, enabling future data analyses. According to our preliminary review, at least 400 patients of the retrospective cohort have completed epidemiologic, MRI, microbiological, and clinical data. The epidemiological data include age, gender, disc herniation relapse, epidural steroid injection before the surgery, body mass index (BMI), the lumbar segment of herniation, type of herniation, and physical workload. The clinical data include microbiological findings from perioperatively collected disc tissue, preoperative spinal MRI, preoperative and postoperative pain intensity according to the visual analog scale (VAS), and functional disability for low back pain quantified by the Oswestry Disability Questionnaire (ODQ). Although the data is available, no hypotheses between C. acnes positivity and clinical outcomes have yet been tested on the dataset. Therefore, in this part of the project, microbiological findings will be studied together with radiological changes in preoperative MRI and clinical status before and after surgery.
Prospective data cohort
Patient enrollment - the investigators plan to enrol at least 400 patients with lumbar disc herniation indicated for microdiscectomy at the Department of Neurosurgery, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic. Patients indicated for lumbar microdiscectomy will be prospectively screened, and those who pass the inclusion and exclusion criteria will be asked to sign the Informed Consent form to be enrolled in the study.
Preoperative data collection - baseline epidemiological and clinical data such as age, gender, disc herniation relapse, epidural steroid injection before the surgery, body mass index (BMI), the lumbar segment of herniation, type of herniation, and physical workload will be collected from each patient. Degenerative changes in the intervertebral discs and adjacent spinal structures will be evaluated on MRI as part of a standard preoperative examination. Clinical data will be obtained during the preoperative clinical exam and from patients in the form of questionnaires, including a numerical scale for leg and back pain, the Oswestry questionnaire evaluating the impact of low back pain on activities of daily living, and the Short Form quality of life questionnaire - 36 (SF- 36) to examine the quality of life before surgery.
Perioperative tissue collection - all operations for herniated intervertebral discs in patients included in the project will be performed at the Department of Neurosurgery, Faculty of Medicine, Masaryk University, and St. Anne's University Hospital, Brno, Czech Republic. The surgical site will undergo a comprehensive preparation, including three meticulous applications of povidone-iodine or an adequate antiseptic in case of iodine allergy. The site will then be draped using a standard sterile technique. Common prophylactic antibiotics will be given preoperatively in a single intravenous dose in all cases, with the usual prophylactic antibiotic being cefazolin; clindamycin or vancomycin will be administered in case of allergy. The exact location of the skin incision will be guided by intraoperative fluoroscopy. In all cases, a posterior midline approach will be used. The Caspar-type self-retaining retractor will be placed, and the ligamentum flavum will be removed under an operating microscope using Penfield dissectors and Kerrison rongeurs. The nerve root and dural sac will be gently retracted, and the posterior longitudinal ligament will be incised at the site of the herniated disc. The disc herniation will be exposed and removed with the remnant fragments of the nucleus pulposus in the intervertebral space. To minimize contamination of tissue samples, they will be retained in a sterile sample cup, labeled, and transported to the Department of Microbiology at St. Anne's University Hospital, Brno, Czech Republic. Tissue samples ranging from 3x3x5 mm to 10x5x5 mm will be utilized immediately for microbiological processing.
Microbiological examination - based on the preliminary study, the investigators plan to process the samples (semi)quantitatively. The samples will be homogenized by disintegration in a stomacher. Subsequently, the samples will be inoculated onto suitable culture media and cultured aerobically and anaerobically with subsequent semi-quantitative evaluation of the results. The quantity of bacteria in the sample will be expressed as colony-forming units (CFU) in 1 g of the sample. C. acnes burden in the sample exceeding 103 CFU/gram (≥103 CFU/gram) will be considered a clinically significant finding; C. acnes burden below <102 CFU/gram will indicate contamination; ≥102 - <103 CFU/gram will be interpreted as a borderline result.
Taxonomic identification of isolated strains will be performed by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) as well as conventional phenotypic methods (biochemical tests, microscopy, etc.). For the phylotyping of our isolates, the investigators will use the multiplex PCR. To assess the ability to form a biofilm, the investigators will use the microtiter plate-based assay. The assay needs to be optimized, particularly with regard to suitable culture conditions and suitable treatment of the adhesion surfaces (peptide coating). A CAMP factor will be tested using the CAMP test with Staphylococcus aureus (CCM 6188). Hemolytic activity will be assessed using the blood agar with washed sheep erythrocytes. The production of some other virulence factors, e.g., hyaluronidase decapsulation test, chondroitin sulfatase, hyaluronidase, deoxyribonuclease, gelatinase, phosphatase, and lecithinase, will also be monitored. Antimicrobial susceptibility testing will be performed using phenotypic methods, broth microdilution, and/or standardized disk diffusion methods, according to the European Committee on Antimicrobial Susceptibility Testing - EUCAST Antimicrobial Susceptibility Testing (available at https://www.eucast.org/ast_of_bacteria).
Postoperative follow-up visits - postoperative clinical condition and the overall outcome will be evaluated by patients using the same standardized exams and questionnaires as before the surgery (numerical pain scale for leg and back, the Oswestry questionnaire, the Short Form quality of life questionnaire - 36 (SF-36). In addition to the mentioned questionnaires, patients will evaluate the success of the surgical treatment using the modified MacNab criteria and their satisfaction with the surgical treatment using the North American Spine Society (NASS) patient satisfaction index. Follow-up on-site visits will be carried out according to the standards of the Department of Neurosurgery, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic, 6 weeks (± 1week), 6 months (± 2weeks), and 12 months (± 2weeks) after the operation.
- Keywords
- Cutibacterium acnes, Degenerative disc disease, Low back pain, Microdiscectomy, Clinical outcome
- Medical subject headings
- Intervertebral Disc Displacement, Intervertebral Disc Degeneration, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| prospective | 1. Patient enrollment: We plan to prospectively enroll at least 400 patients with lumbar disc herniation indicated for lumbar microdiscectomy 2. Preoperative data collection: Baseline epidemiological, radiological and clinical data including survey questionnaires will be collected from each patient. 3. Peri-operative tissue collection: Peri-operatively collected tissue samples of the herniated intervertebral disc will be immediately sent for histological examination. 4. Microbiological examination: The presence, quantification, phylotyping of C.acnes and other bacteria, including virulence factors and antimicrobial susceptibility in the collected disc tissue will be examined by a microbiologist. 5. Post-operative follow-up visits: Post-operative clinical status will be assessed using questionnaires at follow-up visits at 6 weeks, 6, and 12 months after surgery | |
| retrospective | All patients in retrospective cohort have completed epidemiologic, MRI or CT, microbiological, and clinical data. The epidemiological data include age, gender, disc herniation relapse, epidural steroid injection before the surgery, body mass index (BMI), the lumbar segment of herniation, type of herniation, and physical workload. The clinical data include microbiological findings from perioperatively collected disc tissue, preoperative spinal MRI, preoperative and postoperative pain intensity according to the visual analog scale (VAS), and functional disability for low back pain quantified by the Oswestry Disability Questionnaire (ODQ). In this part of the project, microbiological findings will be studied together with radiological changes in preoperative MRI and clinical status before and after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of C. acnes on functional disability in patients after microdiscectomy.
The primary aim is a questionnaire-based comparison of the dynamics of the functional limitations according to ODI score between patients with different C. acnes bacterial load and C. acnes isolates in the disc tissue following microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
Secondary outcomes (41)
The effect of C. acnes on functional disability in patients after microdiscectomy.
The primary aim is a questionnaire-based comparison of the dynamics of the functional limitations according to ODI score between patients with different C. acnes bacterial load and C. acnes isolates in the disc tissue following microdiscectomy.
Measured: 6 months (± 2weeks) after surgery.
The effect of C. acnes on functional disability in patients after microdiscectomy.
The primary aim is a questionnaire-based comparison of the dynamics of the functional limitations according to ODI score between patients with different C. acnes bacterial load and C. acnes isolates in the disc tissue following microdiscectomy.
Measured: 12 months (± 2weeks) after the operation.
The effect of C. acnes on radicular pain in patients after microdiscectomy.
The secondary aim is a questionnaire-based comparison of the dynamics of radicular pain according to NRS between groups with different C. acnes bacterial load and C. acnes isolates in the disc tissue c
Measured: 6 weeks (± 1week) after the operation.
The effect of C. acnes on radicular pain in patients after microdiscectomy.
The secondary aim is a questionnaire-based comparison of the dynamics of radicular pain according to NRS between groups with different C. acnes bacterial load and C. acnes isolates in the disc tissue c
Measured: 6 months (± 2weeks) after the operation.
The effect of C. acnes on radicular pain in patients after microdiscectomy.
The secondary aim is a questionnaire-based comparison of the dynamics of radicular pain according to NRS between groups with different C. acnes bacterial load and C. acnes isolates in the disc tissue c
Measured: 12 months (± 2weeks) after the operation.
The effect of C. acnes on low back pain in patients after microdiscectomy.
The primary endpoint is a questionnaire-based comparison of the dynamics of low back pain according to NRS in patients with different C. acnes bacterial load and C. acnes isolates in the disc tissue following microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
The effect of C. acnes on low back pain in patients after microdiscectomy.
The primary endpoint is a questionnaire-based comparison of the dynamics of low back pain according to NRS in patients with different C. acnes bacterial load and C. acnes isolates in the disc tissue following microdiscectomy.
Measured: 6 months (± 2weeks) after the operation.
The effect of C. acnes on low back pain in patients after microdiscectomy.
The primary endpoint is a questionnaire-based comparison of the dynamics of low back pain according to NRS in patients with different C. acnes bacterial load and C. acnes isolates in the disc tissue following microdiscectomy.
Measured: 12 months (± 2weeks) after the operation.
The effect of C. acnes on quality of life in patients after microdiscectomy.
The secondary aim is to compare the dynamics of overall health status using SF-36 questionnaire in patients after microdiscectomy with different C. acnes bacterial load and C. acnes isolates in the disc tissue.
Measured: 6 weeks (± 1week) after the operation.
The effect of C. acnes on quality of life in patients after microdiscectomy.
The secondary aim is to compare the dynamics of overall health status using SF-36 questionnaire in patients after microdiscectomy with different C. acnes bacterial load and C. acnes isolates in the disc tissue.
Measured: 6 months (± 2weeks) after the operation.
The effect of C. acnes on quality of life in patients after microdiscectomy.
The secondary aim is to compare the dynamics of overall health status using SF-36 questionnaire in patients after microdiscectomy with different C. acnes bacterial load and C. acnes isolates in the disc tissue.
Measured: 12 months (± 2weeks) after the operation.
The influence of C. acnes on the success of surgical treatment in patients after microdiscectomy.
The secondary aim is a questionnaire-based comparison of success of surgical treatment according to MacNab criteria, between groups with different C. acnes bacterial load and C. acnes isolates in the disc tissue at different time intervals following microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
The influence of C. acnes on the success of surgical treatment in patients after microdiscectomy.
The secondary aim is a questionnaire-based comparison of success of surgical treatment according to MacNab criteria, between groups with different C. acnes bacterial load and C. acnes isolates in the disc tissue at different time intervals following microdiscectomy.
Measured: 6 months (± 2weeks) after the operation.
The influence of C. acnes on the success of surgical treatment in patients after microdiscectomy.
The secondary aim is a questionnaire-based comparison of success of surgical treatment according to MacNab criteria, between groups with different C. acnes bacterial load and C. acnes isolates in the disc tissue at different time intervals following microdiscectomy.
Measured: 12 months (± 2weeks) after the operation.
The influence of C. acnes on patient satisfaction after microdiscectomy.
The secondary objective is to compare patient satisfaction with surgical treatment according to the NASS patient satisfaction index criteria, between groups with different C. acnes bacterial load and C. acnes isolates in disc tissue at different time intervals after microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
The influence of C. acnes on patient satisfaction after microdiscectomy.
The secondary objective is to compare patient satisfaction with surgical treatment according to the NASS patient satisfaction index criteria, between groups with different C. acnes bacterial load and C. acnes isolates in disc tissue at different time intervals after microdiscectomy.
Measured: 6 months (± 2weeks) after the operation.
The influence of C. acnes on patient satisfaction after microdiscectomy.
The secondary objective is to compare patient satisfaction with surgical treatment according to the NASS patient satisfaction index criteria, between groups with different C. acnes bacterial load and C. acnes isolates in disc tissue at different time intervals after microdiscectomy.
Measured: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on radicular pain in patients after microdiscectomy.
Evaluation of the presence of other bacteria in disc tissue and their clinical significance using a questionnaire-based comparison of radicular pain according to NRS at different time intervals after microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their effect on radicular pain in patients after microdiscectomy.
Evaluation of the presence of other bacteria in disc tissue and their clinical significance using a questionnaire-based comparison of radicular pain according to NRS at different time intervals after microdiscectomy.
Measured: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on radicular pain in patients after microdiscectomy
Evaluation of the presence of other bacteria in disc tissue and their clinical significance using a questionnaire-based comparison of radicular pain according to NRS at different time intervals after microdiscectomy
Measured: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on low back pain in patients after microdiscectomy
Evaluation of the presence of other bacteria in disc tissue and their clinical significance using a questionnaire-based comparison of low back pain according to NRS at different time intervals after microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their effect on low back pain in patients after microdiscectomy.
Evaluation of the presence of other bacteria in disc tissue and their clinical significance using a questionnaire-based comparison of low back pain according to NRS at different time intervals after microdiscectomy.
Measured: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on low back pain in patients after microdiscectomy
Evaluation of the presence of other bacteria in disc tissue and their clinical significance using a questionnaire-based comparison of low back pain according to NRS at different time intervals after microdiscectomy.
Measured: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on functional disability in patients after microdiscectomy.
Evaluation of the presence of other bacteria in disc tissue and their clinical significance using a questionnaire-based comparison of functional disability according to ODI score at different time intervals after microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their effect on functional disability in patients after microdiscectomy
Evaluation of the presence of other bacteria in disc tissue and their clinical significance using a questionnaire-based comparison of functional disability according to ODI score at different time intervals after microdiscectomy.
Measured: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on functional disability in patients after microdiscectomy
Evaluation of the presence of other bacteria in disc tissue and their clinical significance using a questionnaire-based comparison of functional disability according to ODI score at different time intervals after microdiscectomy.
Measured: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on the quality of life in patients after microdiscectomy.
Evaluation of the presence of other bacteria in the disc tissue and their role in the success of surgical treatment using SF-36 questionnaire-based comparison at different time intervals after microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their effect on the quality of life in patients after microdiscectomy.
Evaluation of the presence of other bacteria in the disc tissue and their role in the success of surgical treatment using SF-36 questionnaire-based comparison at different time intervals after microdiscectomy.
Measured: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on the quality of life in patients after microdiscectomy.
Evaluation of the presence of other bacteria in the disc tissue and their role in the success of surgical treatment using SF-36 questionnaire-based comparison at different time intervals after microdiscectomy.
Measured: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their role in the success of surgical treatment in patients after microdiscectomy
Evaluation of the presence of other bacteria in the disc tissue and their role in the success of surgical treatment using MacNab criteria at different time intervals after microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their role in the success of surgical treatment in patients after microdiscectomy
Evaluation of the presence of other bacteria in the disc tissue and their role in the success of surgical treatment using MacNab criteria at different time intervals after microdiscectomy.
Measured: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their role in the success of surgical treatment in patients after microdiscectomy
Evaluation of the presence of other bacteria in the disc tissue and their role in the success of surgical treatment using MacNab criteria at different time intervals after microdiscectomy.
Measured: 12 months (± 2weeks) after the operation.
The presence of other bacteria in disc tissue and their role in patient satisfaction after microdiscectomy
Evaluation of the presence of other bacteria in disc tissue and their role in patient satisfaction with surgical treatment using the NASS patient satisfaction index at different time intervals following microdiscectomy.
Measured: 6 weeks (± 1week) after the operation.
The presence of other bacteria in disc tissue and their role in patient satisfaction after microdiscectomy
Evaluation of the presence of other bacteria in disc tissue and their role in patient satisfaction with surgical treatment using the NASS patient satisfaction index at different time intervals following microdiscectomy.
Measured: 6 months (± 2weeks) after the operation.
The presence of other bacteria in disc tissue and their role in patient satisfaction after microdiscectomy
Evaluation of the presence of other bacteria in disc tissue and their role in patient satisfaction with surgical treatment using the NASS patient satisfaction index at different time intervals following microdiscectomy.
Measured: 12 months (± 2weeks) after the operation.
Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on preoperative radicular pain.
A retrospective evaluation of our cohort of more than a thousand patients enrolled in a prospective study evaluating the presence of C. acnes in intervertebral disc tissue collected during microdiscectomy. Comparison of patients with different bacterial loads of C. acnes in disc tissue and their effect on preoperative radicular pain according to NRS.
Measured: Processing of retrospective data up to one year after the start of the study.
Retrospective evaluation of the effect of different C. acnes bacterial load in disc tissue on preoperative low back pain.
A retrospective evaluation of our cohort of more than a thousand patients enrolled in a prospective study evaluating the presence of C. acnes in intervertebral disc tissue collected during microdiscectomy. Comparison of patients with different bacterial loads of C. acnes in disc tissue and their effect on preoperative low back pain according to NRS.
Measured: Processing of retrospective data up to one year after the start of the study.
Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on preoperative functional disability
A retrospective evaluation of our cohort of more than a thousand patients enrolled in a prospective study evaluating the presence of C. acnes in intervertebral disc tissue collected during microdiscectomy. Comparison of patients with different bacterial loads of C. acnes in disc tissue and their effect on preoperative functional disability according to ODI score.
Measured: Processing of retrospective data up to one year after the start of the study
Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on the occurrence of Modic changes on preoperative MRI
A retrospective evaluation of our cohort of more than a thousand patients enrolled in a prospective study evaluating the presence of C. acnes in intervertebral disc tissue collected during microdiscectomy. Comparison of patients with different bacterial loads of C. acnes in disc tissue and their possible relationship with the occurrence of Modic changes on preoperative MRI.
Measured: Processing of retrospective data up to one year after the start of the study.
Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on the severity of degenerative changes in the intervertebral disc.
A retrospective evaluation of our cohort of more than a thousand patients enrolled in a prospective study evaluating the presence of C. acnes in intervertebral disc tissue collected during microdiscectomy. Comparison of patients with different bacterial loads of C. acnes in disc tissue and their possible relationship with the severity of intervertebral disc degeneration according to Pfirrmann score.
Measured: Processing of retrospective data up to one year after the start of the study
Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on the severity of vertebral endplate damage.
A retrospective evaluation of our cohort of more than a thousand patients enrolled in a prospective study evaluating the presence of C. acnes in intervertebral disc tissue collected during microdiscectomy. Comparison of patients with different bacterial loads of C. acnes in disc tissue and their possible relationship with the severity of vertebral endplate damage according to Endplate Damage Score.
Measured: Processing of retrospective data up to one year after the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085247
- Sponsor's protocol ID
- NW25J-10-00060
- Status last verified
- Jul 2025
- First submitted
- 29 Apr 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cutibacterium Acnes in the Development of Degenerative Lumbar Intervertebral Disc Disease and the Clinical Effect of Microdiscectomy
- ClinicalTrials.gov ID
- NCT07085247
- Acronym / sponsor ID
- NW25J-10-00060
- Keywords
- Cutibacterium acnes, Degenerative disc disease, Low back pain, Microdiscectomy, Clinical outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to clarify the role of the bacterium Cutibacterium acnes in the development of degenerative disc disease in patients with lumbar disc herniation who underwent microdiscectomy as part of their regular medical care.
Detailed description
The project is divided into retrospective and prospective parts. The retrospective part will consist of data processing and analysis using our large cohort of patients enrolled during the previous studies. The prospective part will include a) patient enrollment, b) preoperative data collection, c) perioperative tissue collection, d) microbiological examination, e) postoperative follow-up visits, and f) data management and statistical analyses.
Retrospective data processing and analysis For the retrospective part of the project, the investigators plan to use the C. acnes database stored at the Department of Neurosurgery, St. Anne's University Hospital, Brno, Czech Republic. This database contains 1200 anonymized adult patients with symptomatic lumbar disc herniation scheduled for microdiscectomy between 2015 and 2024. These patients were enrolled during the research project entitled "Presence of the low-virulence bacterium Propionibacterium acnes in the intervertebral disc tissue as a cause of chronic back pain". Each patient signed informed consent forms before enrolling in this study, enabling future data analyses. According to our preliminary review, at least 400 patients of the retrospective cohort have completed epidemiologic, MRI, microbiological, and clinical data. The epidemiological data include age, gender, disc herniation relapse, epidural steroid injection before the surgery, body mass index (BMI), the lumbar segment of herniation, type of herniation, and physical workload. The clinical data include microbiological findings from perioperatively collected disc tissue, preoperative spinal MRI, preoperative and postoperative pain intensity according to the visual analog scale (VAS), and functional disability for low back pain quantified by the Oswestry Disability Questionnaire (ODQ). Although the data is available, no hypotheses between C. acnes positivity and clinical outcomes have yet been tested on the dataset. Therefore, in this part of the project, microbiological findings will be studied together with radiological changes in preoperative MRI and clinical status before and after surgery.
Prospective data cohort
Patient enrollment - the investigators plan to enrol at least 400 patients with lumbar disc herniation indicated for microdiscectomy at the Department of Neurosurgery, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic. Patients indicated for lumbar microdiscectomy will be prospectively screened, and those who pass the inclusion and exclusion criteria will be asked to sign the Informed Consent form to be enrolled in the study.
Preoperative data collection - baseline epidemiological and clinical data such as age, gender, disc herniation relapse, epidural steroid injection before the surgery, body mass index (BMI), the lumbar segment of herniation, type of herniation, and physical workload will be collected from each patient. Degenerative changes in the intervertebral discs and adjacent spinal structures will be evaluated on MRI as part of a standard preoperative examination. Clinical data will be obtained during the preoperative clinical exam and from patients in the form of questionnaires, including a numerical scale for leg and back pain, the Oswestry questionnaire evaluating the impact of low back pain on activities of daily living, and the Short Form quality of life questionnaire - 36 (SF- 36) to examine the quality of life before surgery.
Perioperative tissue collection - all operations for herniated intervertebral discs in patients included in the project will be performed at the Department of Neurosurgery, Faculty of Medicine, Masaryk University, and St. Anne's University Hospital, Brno, Czech Republic. The surgical site will undergo a comprehensive preparation, including three meticulous applications of povidone-iodine or an adequate antiseptic in case of iodine allergy. The site will then be draped using a standard sterile technique. Common prophylactic antibiotics will be given preoperatively in a single intravenous dose in all cases, with the usual prophylactic antibiotic being cefazolin; clindamycin or vancomycin will be administered in case of allergy. The exact location of the skin incision will be guided by intraoperative fluoroscopy. In all cases, a posterior midline approach will be used. The Caspar-type self-retaining retractor will be placed, and the ligamentum flavum will be removed under an operating microscope using Penfield dissectors and Kerrison rongeurs. The nerve root and dural sac will be gently retracted, and the posterior longitudinal ligament will be incised at the site of the herniated disc. The disc herniation will be exposed and removed with the remnant fragments of the nucleus pulposus in the intervertebral space. To minimize contamination of tissue samples, they will be retained in a sterile sample cup, labeled, and transported to the Department of Microbiology at St. Anne's University Hospital, Brno, Czech Republic. Tissue samples ranging from 3x3x5 mm to 10x5x5 mm will be utilized immediately for microbiological processing.
Microbiological examination - based on the preliminary study, the investigators plan to process the samples (semi)quantitatively. The samples will be homogenized by disintegration in a stomacher. Subsequently, the samples will be inoculated onto suitable culture media and cultured aerobically and anaerobically with subsequent semi-quantitative evaluation of the results. The quantity of bacteria in the sample will be expressed as colony-forming units (CFU) in 1 g of the sample. C. acnes burden in the sample exceeding 103 CFU/gram (≥103 CFU/gram) will be considered a clinically significant finding; C. acnes burden below <102 CFU/gram will indicate contamination; ≥102 - <103 CFU/gram will be interpreted as a borderline result.
Taxonomic identification of isolated strains will be performed by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) as well as conventional phenotypic methods (biochemical tests, microscopy, etc.). For the phylotyping of our isolates, the investigators will use the multiplex PCR. To assess the ability to form a biofilm, the investigators will use the microtiter plate-based assay. The assay needs to be optimized, particularly with regard to suitable culture conditions and suitable treatment of the adhesion surfaces (peptide coating). A CAMP factor will be tested using the CAMP test with Staphylococcus aureus (CCM 6188). Hemolytic activity will be assessed using the blood agar with washed sheep erythrocytes. The production of some other virulence factors, e.g., hyaluronidase decapsulation test, chondroitin sulfatase, hyaluronidase, deoxyribonuclease, gelatinase, phosphatase, and lecithinase, will also be monitored. Antimicrobial susceptibility testing will be performed using phenotypic methods, broth microdilution, and/or standardized disk diffusion methods, according to the European Committee on Antimicrobial Susceptibility Testing - EUCAST Antimicrobial Susceptibility Testing (available at https://www.eucast.org/ast_of_bacteria).
Postoperative follow-up visits - postoperative clinical condition and the overall outcome will be evaluated by patients using the same standardized exams and questionnaires as before the surgery (numerical pain scale for leg and back, the Oswestry questionnaire, the Short Form quality of life questionnaire - 36 (SF-36). In addition to the mentioned questionnaires, patients will evaluate the success of the surgical treatment using the modified MacNab criteria and their satisfaction with the surgical treatment using the North American Spine Society (NASS) patient satisfaction index. Follow-up on-site visits will be carried out according to the standards of the Department of Neurosurgery, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic, 6 weeks (± 1week), 6 months (± 2weeks), and 12 months (± 2weeks) after the operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prospective | – | –1. Patient enrollment: We plan to prospectively enroll at least 400 patients with lumbar disc herniation indicated for lumbar microdiscectomy 2. Preoperative data collection: Baseline epidemiological, radiological and clinical data including survey questionnaires will be collected from each patient. 3. Peri-operative tissue collection: Peri-operatively collected tissue samples of the herniated intervertebral disc will be immediately sent for histological examination. 4. Microbiological examination: The presence, quantification, phylotyping of C.acnes and other bacteria, including virulence factors and antimicrobial susceptibility in the collected disc tissue will be examined by a microbiologist. 5. Post-operative follow-up visits: Post-operative clinical status will be assessed using questionnaires at follow-up visits at 6 weeks, 6, and 12 months after surgery |
| retrospective | – | –All patients in retrospective cohort have completed epidemiologic, MRI or CT, microbiological, and clinical data. The epidemiological data include age, gender, disc herniation relapse, epidural steroid injection before the surgery, body mass index (BMI), the lumbar segment of herniation, type of herniation, and physical workload. The clinical data include microbiological findings from perioperatively collected disc tissue, preoperative spinal MRI, preoperative and postoperative pain intensity according to the visual analog scale (VAS), and functional disability for low back pain quantified by the Oswestry Disability Questionnaire (ODQ). In this part of the project, microbiological findings will be studied together with radiological changes in preoperative MRI and clinical status before and after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to enroll at least 400 patients with lumbar disc herniation indicated for microdiscectomy at the Department of Neurosurgery, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic. Patients indicated for lumbar microdiscectomy will be prospectively screened, and those who pass the inclusion and exclusion criteria will be asked to sign the Informed Consent form to be enrolled in the study.
Key inclusion criteria (3 listed)
- minimum age of 18 years
- MRI of the lumbosacral spine performed one month ± 2weeks before surgery showing a disc protrusion, herniation, or free nucleus pulposus sequestration
- matching physical examination findings including positive straight leg raise test, dermatomal sensory deficits, myotome motor deficits, and diminished deep tendon reflexes.
Key exclusion criteria (7 listed)
- antibiotics or corticosteroid use the month before surgery
- ongoing bacterial or viral infection
- immunocompromised patient
- trauma
- undefined radiological mass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The effect of C. acnes on functional disability in patients after microdiscectomy.
Time frame: 6 weeks (± 1week) after the operation.
The primary aim is a questionnaire-based comparison of the dynamics of the functional limitations according to ODI score between patients with different C. acnes bacterial load and C. acnes isolates in the disc tissue following microdiscectomy.
41 secondary outcomes
The effect of C. acnes on functional disability in patients after microdiscectomy.
Time frame: 6 months (± 2weeks) after surgery.
The effect of C. acnes on functional disability in patients after microdiscectomy.
Time frame: 12 months (± 2weeks) after the operation.
The effect of C. acnes on radicular pain in patients after microdiscectomy.
Time frame: 6 weeks (± 1week) after the operation.
The effect of C. acnes on radicular pain in patients after microdiscectomy.
Time frame: 6 months (± 2weeks) after the operation.
The effect of C. acnes on radicular pain in patients after microdiscectomy.
Time frame: 12 months (± 2weeks) after the operation.
The effect of C. acnes on low back pain in patients after microdiscectomy.
Time frame: 6 weeks (± 1week) after the operation.
The effect of C. acnes on low back pain in patients after microdiscectomy.
Time frame: 6 months (± 2weeks) after the operation.
The effect of C. acnes on low back pain in patients after microdiscectomy.
Time frame: 12 months (± 2weeks) after the operation.
The effect of C. acnes on quality of life in patients after microdiscectomy.
Time frame: 6 weeks (± 1week) after the operation.
The effect of C. acnes on quality of life in patients after microdiscectomy.
Time frame: 6 months (± 2weeks) after the operation.
The effect of C. acnes on quality of life in patients after microdiscectomy.
Time frame: 12 months (± 2weeks) after the operation.
The influence of C. acnes on the success of surgical treatment in patients after microdiscectomy.
Time frame: 6 weeks (± 1week) after the operation.
The influence of C. acnes on the success of surgical treatment in patients after microdiscectomy.
Time frame: 6 months (± 2weeks) after the operation.
The influence of C. acnes on the success of surgical treatment in patients after microdiscectomy.
Time frame: 12 months (± 2weeks) after the operation.
The influence of C. acnes on patient satisfaction after microdiscectomy.
Time frame: 6 weeks (± 1week) after the operation.
The influence of C. acnes on patient satisfaction after microdiscectomy.
Time frame: 6 months (± 2weeks) after the operation.
The influence of C. acnes on patient satisfaction after microdiscectomy.
Time frame: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on radicular pain in patients after microdiscectomy.
Time frame: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their effect on radicular pain in patients after microdiscectomy.
Time frame: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on radicular pain in patients after microdiscectomy
Time frame: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on low back pain in patients after microdiscectomy
Time frame: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their effect on low back pain in patients after microdiscectomy.
Time frame: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on low back pain in patients after microdiscectomy
Time frame: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on functional disability in patients after microdiscectomy.
Time frame: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their effect on functional disability in patients after microdiscectomy
Time frame: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on functional disability in patients after microdiscectomy
Time frame: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on the quality of life in patients after microdiscectomy.
Time frame: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their effect on the quality of life in patients after microdiscectomy.
Time frame: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their effect on the quality of life in patients after microdiscectomy.
Time frame: 12 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their role in the success of surgical treatment in patients after microdiscectomy
Time frame: 6 weeks (± 1week) after the operation.
Presence of other bacteria in disc tissue and their role in the success of surgical treatment in patients after microdiscectomy
Time frame: 6 months (± 2weeks) after the operation.
Presence of other bacteria in disc tissue and their role in the success of surgical treatment in patients after microdiscectomy
Time frame: 12 months (± 2weeks) after the operation.
The presence of other bacteria in disc tissue and their role in patient satisfaction after microdiscectomy
Time frame: 6 weeks (± 1week) after the operation.
The presence of other bacteria in disc tissue and their role in patient satisfaction after microdiscectomy
Time frame: 6 months (± 2weeks) after the operation.
The presence of other bacteria in disc tissue and their role in patient satisfaction after microdiscectomy
Time frame: 12 months (± 2weeks) after the operation.
Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on preoperative radicular pain.
Time frame: Processing of retrospective data up to one year after the start of the study.
Retrospective evaluation of the effect of different C. acnes bacterial load in disc tissue on preoperative low back pain.
Time frame: Processing of retrospective data up to one year after the start of the study.
Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on preoperative functional disability
Time frame: Processing of retrospective data up to one year after the start of the study
Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on the occurrence of Modic changes on preoperative MRI
Time frame: Processing of retrospective data up to one year after the start of the study.
Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on the severity of degenerative changes in the intervertebral disc.
Time frame: Processing of retrospective data up to one year after the start of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Lumbar Disc Degeneration, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Solár, MUDr., Ph.D. (+420 770 638 756, peter.solar@fnusa.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of C. acnes on functional disability in patients after microdiscectomy. (time frame: 6 weeks (± 1week) after the operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.